The impact and indications for Oncotype DX on adjuvant treatment recommendations when third-party funding is unavailable

L. Chin-Lenn, R. H. De Boer, E. Segelov, G. M. Marx, T. M. Hughes, N. J. McCarthy, S. C. White, S. S. Foo, J. J. Rutovitz, S. Della-Fiorentina, R. Jennens, Y. C. Antill, D. Tsoi, M. F. Cronk, J. M. Lombard, B. E. Kiely, J. H. Chirgwin, A. Gorelik, G. B. Mann

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Abstract

Objectives: Industry-supported decision impact studies demonstrate that Oncotype Dx (ODX) changes treatment recommendations (TR) in 24–40% of hormone receptor+/HER2− patients. ODX is not reimbursed by third-party payers in Australia, potentially resulting in more selective use. We sought to evaluate the impact of self-funded ODX on TRs. Methods: Data collected included demographics, tumor characteristics, indication for ODX and pre- and post-recurrence score (RS) TR. Primary endpoint was frequency of TR change and associations with TR change were sought. Results: Eighteen physicians contributed 382 patients (median age 54). A total of 232 (61%) of tumors were T1 and were grade 1, 2 and 3 in 49 (13%), 252 (66%) and 79 (21%). A total of 257 (67%) were node negative. Assay indications were: confirm need for chemotherapy (CT) (36%), confirm omission of CT (40%) and genuine equipoise (24%). RS was low (≤17) in 55%, intermediate (18-31) in 36% and high (≥32) in 9%. Thirty-eight percent of patients had TR change post-ODX. Sixty-five percent of patients recommended CT pre-ODX changed to hormone therapy alone (HT)—more likely if lower grade and if ER and/or PR > 10%. Fourteen percent of patients with pre-ODX TR for HT added CT—more likely if ER and/or PR ≤10% and if Ki67 > 15% Overall, TR for CT decreased from 47% to 24%. Conclusion: Patient-funded ODX changed TRs in 38% of patients, de-escalating 65% from CT to HT and adding CT to 14% of those recommended HT. These changes were greater than an industry-funded study suggesting that physicians can identify situations where the assay may influence decisions.

Original languageEnglish
Pages (from-to)410-416
Number of pages7
JournalAsia-Pacific Journal of Clinical Oncology
Volume14
Issue number6
DOIs
Publication statusPublished - Dec 2018
Externally publishedYes

Keywords

  • adjuvant chemotherapy
  • HER2-negative early breast cancer
  • hormone receptor-positive
  • multigene assay
  • treatment decision

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